Health TrialsbyHealthPanel

MS-ResearchBiomarkerS

ConditionsMultiple SclerosisMultiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Primary ProgressiveMultiple Sclerosis, Secondary ProgressiveClinically Isolated SyndromeRadiologically Isolated SyndromeNeuromyelitis Optica Spectrum DisordersMyelin Oligodendrocyte Glycoprotein Antibody-associated DiseaseNeurologic Autoimmune DiseaseNeurologic DisorderHealthy Aging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center

About this trial

This study is being conducted to investigate risk factors for disability progression in Multiple Sclerosis and related disorders (MSRD). The primary goal is to assess whether combining information from visual assessment, blood markers, as well as historical and ongoing longitudinal MRIs of the brain, orbit (the part of the skull where eyes are located), and/or spinal cord can predict changes in quantitative disability measures related to MSRD and neurological disease.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosis of MS, CIS,or RIS based on the 2017 revised McDonald criteria.

Diagnosis of NMOSD based on the 2015 revised NMOSD consensus diagnostic criteria.

Diagnosis of myelin oligodendrocyte glycoprotein (MOG)-related encephalomyelitis, optic neuritis, or other associated disease.

Diagnosis of neurological disorders other than MSRD.

Disqualifiers

Patients will be excluded from the MRI portions of the study if they have a contraindication to MRI(metallic implantsor foreign bodies, claustrophobia, MRI-incompatible pacemakers, MRI- incompatible prosthetic heart valves).

Patients will be excluded from the MRI portions of the study if they are pregnant, but their demographic, clinical information,and disability measures may still be captured under the study.

Patients will be excluded from the visual assessment portions of the study if they have had any recent ocular surgery (within the past two months), refractive errors of greater than or equal to ±6 diopters or other eye diseases that may affect or confound OCT/OCTA measurements (ex., age-related macular degeneration, advanced geographic atrophy, diabetic retinopathy, glaucoma).

Trial population

Participants with the following conditions or healthy volunteers are eligible to participate in the study: 1. Multiple sclerosis (MS), clinically isolated syndrome (CIS), or radiologically isolated syndrome (RIS) 2. Neuromyelitis optica spectrum disorders (NMOSD) 3. Myelin oligodendrocyte glycoprotein (MOG) antibody associated disorders (MOGAD) 4. Neurological disorder other than MS and related disorders 5. Healthy volunteers

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 5 trial groups
Group A: RRMS, SPMS, PPMS, CIS or RIS
Group B: NMOSD
Group C: MOGAD
Group D: Neurological disorder other than MSRD
Group E: Healthy controls

Trial outcomes

Primary outcomes

1

Identifying risk factors for disability progression

To investigate whether combining information from peripheral blood biomarkers, retinal structural, visual function, as well as historical and ongoing longitudinal MRIs (brain, cervical, and/or thoracic spinal cord) can predict quantitative disability progression risk

Time frame
10 years

Secondary outcomes

1

Effect of disease modifying therapy

Assess the effect modification of various Food and Drug Administration(FDA)-approved disease modifying therapy on disability risk

Time frame
10 years
2

Identify factors associated with visual disability and optic neuropathy in multiple sclerosis and related disorders

Using retinal structural and functional testing, this study will track longitudinal evolution of visual dysfunction and retinal injury

Time frame
10 years
3

Identify serum, genetic, and stem cell-derived biomarkers influencing disability risks

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

Source ClinicalTrials.gov
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